This is a phase 2, double-blind, randomized, placebo-controlled, multi-center, dose-finding study to evaluate the efficacy and safety of Kylo-11 administered subcutaneously compared to placebo in participants with ASCVD and elevated Lp(a).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
204
Administered subcutaneously
Peking University First Hospital
Beijing, Beijing Municipality, China
Percent change from baseline in time-averaged Lp(a) over Weeks 8~26
A MMRM including terms of treatment arm, stratification factors, scheduled visit and the interaction of treatment arm with scheduled visit will be used to estimate the percent change from baseline in time-averaged Lp(a) over Weeks 8\~26. The least squares means (LS means) by treatment arm and the treatment difference (Kylo-11 - placebo) based on the model will be summarized.
Time frame: Baseline, Weeks 8~26
Percent change from baseline in time-averaged Lp(a) over Weeks 38~52
A MMRM including terms of treatment arm, stratification factors, scheduled visit and the interaction of treatment arm with scheduled visit will be used to estimate the percent change from baseline in time-averaged Lp(a) over Weeks 8\~26. The least squares means (LS means) by treatment arm and the treatment difference (Kylo-11 - placebo) based on the model will be summarized.
Time frame: Baseline, Weeks 38~52
Proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52
For proportion of participants achieving Lp(a) \<125 nmol/L and \<75 nmol/L at Week 26 and Week 52, the number of responders in both the Kylo-11 arm and the placebo arm will be calculated separately.
Time frame: Week 26 and Week 52
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